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Biological materials definition

The term “biological materials” includes all of the following:

  • Recombinant or synthetic DNA/RNA (plasmids, cloned materials, oligonucleotides, siRNA)
  • Viral vectors (e.g., lentivirus, retrovirus, adenovirus, AAV)
  • Genetically-modified organisms (animals, microorganisms, plants, insects, cells/cell lines)
  • Human products, including blood, tissues, bodily fluids, clinical specimens
  • Live animals, animal carcasses, or animal products including tissues, cells, blood, or other bodily fluids
  • Pathogenic microorganisms (including human, animal, or plant pathogens)
  • Plants, animals, insects, microorganisms, or cells that produce toxic compounds
  • Select Agents or Select Toxins